NCT06679452

Brief Summary

Over recent decades, Emotion-Focused Therapy, aging, and forgiveness have garnered significant attention in the field of psychology. However, there is a lack of studies on Emotion-Focused Therapy and forgiveness specifically tailored for older adults. This article describes a protocol to assess the feasibility and acceptability of a Randomized Controlled Trial of Emotion-Focused Therapy for the resolution of emotional injury in individuals over the age of 65 in the context of interpersonal offenses. The study is structured as a two-arm, parallel-group randomized trial with a waiting list control. We propose recruiting a sample of 70 participants, randomly assigned to either an immediate intervention group, which will receive Emotion-Focused Therapy over twelve weekly sessions, or a control group that will receive the same therapy after a twelve-week waiting period. Data will be collected in the beginning, middle, and at the end of therapy, and in two planned follow-ups (three and six months after therapy). Once this protocol is implemented, if the therapy proves to be feasible, acceptable, and shows promising results, the findings will inform a large-scale randomized clinical trial to advance the understanding of psychotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 5, 2024

Last Update Submit

November 10, 2024

Conditions

Keywords

Emotion-Focused Therapy; Forgiveness; Aging; Randomized Controlled Trial; Feasibility Protocol

Outcome Measures

Primary Outcomes (3)

  • Enright Forgiveness Inventory-EFI

    EFI is a self-report measure designed to measure the level of forgiveness in response to a specific offense. The EFI consists of 60 items divided into three 20-item subscales that assess affect, behavior, and cognition related to forgiveness, using a 6-point Likert scale. Scores range from 60 to 360, with higher scores indicating higher levels of forgiveness.

    From enrollment to the end of treatment at 12 weeks

  • Letting Go (assessed through the Letting Go Measure; Greenberg et al., 2008):

    The Letting Go is a self-report instrument comprising a single item that evaluates the extent to which individuals have released their negative emotions toward the injurer. Responses are measured on a Likert scale ranging from 1 to 5.

    From enrollment to the end of treatment at 12 weeks

  • The Unfinished Business Feelings and Needs Scale (UFB FN-Greenberg et al., 2008;)

    The Unfinished Business Feelings and Needs Scale (UFB FN-Greenberg et al., 2008; Singh, 1994) consists of a 6-item scale designed to measure the extent to which an individual who has experienced an unfair situation feels acceptance and empathy toward the person who has harmed them, utilizing a 5-point Likert scale.

    From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

  • The European Portuguese World Health Organization Quality of Life Assessment in Older Adults (WHOQOL-OLD)

    From enrollment to the end of treatment at 12 weeks

  • The Geriatric Depression Scale-15 (GDS-15; Matos et al., 2019; Yesavage & Sheikh, 1986)

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

35 participants randomly assigned to the EFT intervention

EXPERIMENTAL

The research will include 35 individuals aged 65 years or older, of both genders, who meet the study's inclusion criteria. Therapy sessions will be conducted individually and in person, in offices suited for psychological practice. Participants residing in senior housing will have the option, subject to agreement with their institution, to have sessions conducted in their facilities. Each session will last one hour and occur weekly over a three-month period, resulting in a total of 12 sessions per participant, in accordance with the EFT protocol for resolving emotional injuries established by Meneses and Greenberg (2019) and adjusted for this population/purposes by Almeida and Cunha (2024);

Other: Emotion-Focused Therapy

35 participants include in a control group (CG).

NO INTERVENTION

35 participants included in a control group (CG), in the form of a waitlist.

Interventions

This feasibility protocol is a two-arm, parallel, double-blinded, RCT aimed at informing a future trial assessing the effectiveness of EFT in resolving emotional injuries in older adults in the context of interpersonal offenses.

35 participants randomly assigned to the EFT intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Our eligibility criteria include being 65 years or older, having experienced an interpersonal offense, residing at home or in a senior residence, stable prescribed medication use, scoring ≥ 26 on the MoCA (Montreal Cognitive Assessment), and fluency in Portuguese or English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Av. Carlos Oliveira Campos - Castelo da Maia 4475-690 Avioso S. Pedro

Maia, Castelo Da Maia, 4475-690, Portugal

Location

Related Publications (9)

  • Buzgova R, Kozakova R, Bobcikova K, Zelenikova R. Predictors of life satisfaction in elders living at home in the Czech Republic. PLoS One. 2023 Mar 30;18(3):e0283772. doi: 10.1371/journal.pone.0283772. eCollection 2023.

    PMID: 36996129BACKGROUND
  • Lopez J, Serrano MI, Gimenez I, Noriega C. Forgiveness Interventions for Older Adults: A Review. J Clin Med. 2021 Apr 26;10(9):1866. doi: 10.3390/jcm10091866.

    PMID: 33925790BACKGROUND
  • Band-Winterstein T, Eisikovits Z, Brownell P, King A. Introduction: exploring older women's perspectives on lifetime abuse. J Elder Abuse Negl. 2024; 36(2):91-92. 10.1080/08946566.2024.2332141.

    BACKGROUND
  • Toussaint LL, Worthington EL, Williams DR, eds. Forgiveness and Health: Scientific Evidence and Theories Relating Forgiveness to Better Health. Springer; 2015. doi: 10.1007/978-94-017-9993-5.

    BACKGROUND
  • Greenberg LJ, Warwar SH, Malcolm WM. Differential effects of Emotion-Focused Therapy and psychoeducation in facilitating forgiveness and letting go of emotional injuries. J Couns Psychol. 2008; 55(2):185-96. doi: 10.1037/0022-0167.55.2.185.

    BACKGROUND
  • Almeida, B., Cunha, C. Time, resentment, and forgiveness: Impact on the well-being of older adults. Trends in Psychology. 2023. https://doi.org/10.1007/s43076-023-00343-2

    BACKGROUND
  • Enright RD, Fitzgibbons RP. Forgiveness therapy: An empirical guide for resolving anger and restoring hope. American Psychological Association; 2015. doi: 10.1037/14526-000.

    BACKGROUND
  • Meneses CW, Greenberg LS. Forgiveness and letting go in Emotion-Focused Therapy. American Psychological Association; 2019. doi: 10.1037/0000144-000.

    BACKGROUND
  • Worthington EL, Wade NG, eds. Handbook of forgiveness. 2nd ed. Routledge; 2020.

    BACKGROUND

Related Links

MeSH Terms

Interventions

Emotion-Focused Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carla Cunha Alexandra Dr, PhD

    University of Maia

    STUDY CHAIR

Central Study Contacts

Bernardo Almeida Bernardo Dr, PhD

CONTACT

Carla Cunha Alexandra Dr, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations